Open Access Highly Accessed Study protocol

The effect of glucosamine sulphate on osteoarthritis: design of a long-term randomised clinical trial [ISRCTN54513166]

Rianne M Rozendaal1*, Bart W Koes1, Harrie Weinans2, Elian J Uitterlinden2, Gerjo JVM van Osch2, Abida Z Ginai3, Jan AN Verhaar2 and Sita MA Bierma-Zeinstra1

Author Affiliations

1 Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, the Netherlands

2 Department of Orthopaedics, Erasmus MC, University Medical Centre Rotterdam, the Netherlands

3 Department of Radiology, Erasmus MC, University Medical Centre Rotterdam, the Netherlands

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BMC Musculoskeletal Disorders 2005, 6:20  doi:10.1186/1471-2474-6-20

Published: 26 April 2005

Abstract

Background

Pharmacological treatment for osteoarthritis (OA) can be divided into two groups: symptom-modifying drugs and disease-modifying drugs. Symptom-modifying drugs are currently the prescription of choice for patients with OA, as disease-modifying drugs are not yet available in usual care. However, there has recently been a lot of debate about glucosamine sulphate (GS), a biological agent that is thought to have both symptom-modifying and disease-modifying properties. This assumption has yet to be proved.

The objective of this article is to present the design of a blind randomised clinical trial that examines the long-term symptom-modifying and disease-modifying effectiveness of GS in patients with hip OA. This trial is ongoing and will finish in March 2006.

Methods/design

Patients with hip OA meeting the ACR-criteria are randomly allocated to either 1500 mg of oral GS or placebo for the duration of two years. The primary outcome measures, which are joint space narrowing (JSN), and change in the pain and function score of the Western Ontario McMaster Universities Osteoarthritis index (WOMAC), are determined at baseline and after two years of follow-up during the final assessment. Intermediate measures at three-month intervals throughout the trial are used to study secondary outcome measures. Secondary outcome measures are changes in WOMAC stiffness score, quality of life, medical consumption, side effects and differences in biomarker CTX-II.